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IRCT20230806059053N1 IRCT 2023-09-15 Kashan University of Medical Sciences The effect of probiotic supplementation on male infertility Evaluating effect of probiotics supplement on semen quality and expression of genes associated with oxidative stress in sperm of asthenozoospermia patients 2023-09-14 anticipated 52 Complete https://irct.ir/trial/71890 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Randomization is done by permutation blocks using random allocation software. 6 blocks of size 4 will be used to distribute samples equally between control and intervention groups. In such manner, the number of each patient is given to the software and the patient group (control or intervention) will be determined. 2-3 Idiopathic oligoasthenoteratospermia. Intervention 1: Intervention group: The group of patients receiving 100 mg capsule of CoQ10 BD and 500 mg capsule of probiotic FamiLact daily for a period of 70 days (after food consumption). The probiotic part of this supplement consists of strains of Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium breu, Bifidobacterium breu, Bifidobacterium breu, Bifidobacterium strum bifidocum. Also, fructo-oligosaccharide is used as a prebiotic (in fact, the food of insects) in this product. Intervention 2: Control group: The group of patients receiving 100 mg capsule of CoQ10 BD (200 mg). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Dr. Elahesadat Seyyedhoseini
Kashan, Qotb-e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5558 9444 Elaheir.1987@gmail.com Kashan University of Medical Sciences scientific Dr. Elahesadat Seyyedhoseini
Kashan, Qotb-e Ravandi Blvd
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5558 9444 Elaheir.1987@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of idiopathic oligoasthenospermia 18 years 40 years Male People who take drugs affecting spermatogenesis such as tamoxifen, HCG, gonadotropin, androgens and cytotoxic drugs such as immunosuppressants, anticonvulsants, and antibiotic or antifungal drugs. People who have a diet rich in probiotics. People who have factors with a clear effect on the condition of asthenozoospermia include: varicocele, epididymovarcitis, prostatitis, history of testicular surgery, testicular trauma, testicular torsion, history of intracytoplasmic sperm injection (ICSI), history of chemotherapy, radiotherapy, abnormality. chromosomal abnormalities, cryptorchidism, hypogonadism, recent history of sexually transmitted diseases, pyospermia, smoking, alcohol, drugs, known hormonal disorders, diabetes, known liver and kidney disease, BMI over 30 Unwillingness to cooperate and participate in the study N46.9 Male infertility, unspecified Treatment - Drugs Other Intervention group: The group of patients receiving 100 mg capsule of CoQ10 BD and 500 mg capsule of probiotic FamiLact daily for a period of 70 days (after food consumption). The probiotic part of this supplement consists of strains of Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium breu, Bifidobacterium breu, Bifidobacterium breu, Bifidobacterium strum bifidocum. Also, fructo-oligosaccharide is used as a prebiotic (in fact, the food of insects) in this product. Control group: The group of patients receiving 100 mg capsule of CoQ10 BD (200 mg) Gene expression. Timepoint: Before the intervention and after the intervention. Method of measurement: Real-time PCR. Sperm concentration. Timepoint: Before the intervention and after the intervention. Method of measurement: Semen sample analysis. Semen volume. Timepoint: Before the intervention and after the intervention. Method of measurement: Semen sample analysis. Percentage of abnormal sperm morphology. Timepoint: Before the intervention and after the intervention. Method of measurement: Semen sample analysis. Percentage of sperm motility. Timepoint: Before the intervention and after the intervention. Method of measurement: Semen sample analysis. Percentage of sperm progressive motility. Timepoint: Before the intervention and after the intervention. Method of measurement: Semen sample analysis. Total antioxidant capacity (TAC). Timepoint: Before the intervention and after the intervention. Method of measurement: ELISA. Malondialdehyde (MDA) level. Timepoint: Before the intervention and after the intervention. Method of measurement: ELISA. Vice Chancellor of Research & Technology Kashan University of Medical Sciences Vice Chancellor of Research & Technology Approved 2023-08-01 Ethics Committee of Kashan University of Medical Sciences 5th of Qotb –e Ravandi Blvd., Kashan Kashan Isfehan Iran (Islamic Republic of)